FDA.reportPublic FDA data

PTS Panels® Creatinine Test Strips

Primary DI
00381931720015
Brand
PTS Panels® Creatinine Test Strips
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
1720
Catalog number
1720
Device description
PTS Panels® Creatinine test strips are in vitro diagnostic devices used to monitor creatinine levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
Published
2016-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFYENZYMATIC METHOD, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010456000BIOSCANNER CREATININE TEST STRIPSPolymer Technology Systems, Inc.2001-06-20JFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381931720015PrimaryGS10
10381931720012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381931720015003819317200153819317200150381931720015
1038193172001210381931720012

GMDN Terms#

Term, Definition table
TermDefinition
Creatinine IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of creatinine in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Bring to room temperature before use.
Special Storage Condition, Specify00Keep away from sunlight Keep dry; Bring to room temperature before use
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep away from sunlightKeep dry; Bring to room temperature before use
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature35 Degrees Fahrenheit45 Degrees Fahrenheit
Storage Environment Temperature35 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)870-5610customerservice@ptsdiagnostics.com
+1(888)877-5610customerservice@ptsdiagnostics.com
+1(877)870-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381931716018PTS Panels® Triglycerides Test Strips171617162016-07-22
00381934770017CholesterolREF 477047702025-06-16
00381934774015PTS Diagnostics Capillary TubesREF 477447742025-06-16
10381934770014CholesterolREF 477047702025-06-16
10381934774012PTS Diagnostics Capillary TubesREF 477447742025-06-16
00381933080018A1CNow Self Check, 8ct.308030802023-10-25
10381933080015A1CNow Self Check, 8ct.308030802023-10-25
00381934750019CardioChek Plus Home Self-Test Analyzer475047502022-04-11
00381934720012CardioChek Plus Home Self-Test Analyzer472047202021-02-08
00381931708013CardioChek® PA analyzer170817082016-07-15
00381931709010CardioChek® Analyzer170917092016-07-15
00381931757011CardioChek® PA Professional Analyzer, Refurbished175717572016-07-15
00381931782013CardioChek® Analyzer; Refurbished178217822016-07-15
00381932700016CardioChek® Plus Professional Analyzer270027002016-07-15
00381932701013CardioChek® Plus Professional Analyzer270127012016-07-15
00381932702010CardioChek® Plus Professional Analyzer, Refurbished270227022016-07-15
00021292015022TRUE+ A1CNow Self Check307530752023-07-30
00381932488013Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30
10021292015029TRUE+ A1CNow Self CheckC8H01-02C8H01-022023-07-30
10381932488010Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JFY2025-02-13
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JFY2024-06-14
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00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
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00630414301587Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
03610230006962Yumizen C1200 Creatinine PAPHORIBA ABX SASJFY2021-06-17
00811727016072Pointe Creatinine, Enzymatic ReagentHORIBA INSTRUMENTS INCORPORATEDJFY2021-01-30
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JFY2020-09-30
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
20885380175562CARDINAL HEALTHCardinal Health 200, LLCJFY2020-06-30
00811727015761Pointe Creatinine Enzymatic on BS480HORIBA INSTRUMENTS INCORPORATEDJFY2020-05-28
07613336121160Creatinine plus ver.2Roche Diagnostics GmbHJFY2020-03-05
10758750031788VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JFY2019-11-13
07070060014630Afinion ACRAbbott Diagnostics Technologies ASJFY2019-05-16
07070060014654Afinion HbA1cAbbott Diagnostics Technologies ASJFY2019-05-16
00386100001995CREA Reagent Kit MEDICA CORPORATIONJFY2019-02-14
00380740136161AlinityABBOTT LABORATORIESJFY2018-08-08
00380740136178AlinityABBOTT LABORATORIESJFY2018-08-08
10673486000573TECO DIAGNOSTICSTECO DIAGNOSTICSJFY2018-02-12